PD Series Maestro Perforator Chuck Instructions for Use Rev AB July 2020

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5400-210-714 Rev-AB

Introduction This Instructions For Use manual is the most comprehensive source of information for the safe and effective use of your product. This manual may be used by in-service trainers, physicians, nurses, surgical technologists, biomedical equipment technicians, and central supply/sterile processing technicians. Keep and consult this reference manual during the life of the product. The following conventions are used in this manual: • A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury. • A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. • A NOTE supplements and/or clarifies procedural information. For additional information, especially safety information, or inservice training, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. NOTE: The user and/or patient should report any serious productrelated incident to both the manufacturer and the Competent Authority of the European Member State where the user and/or patient is established.

Indications For Use See the instructions for use supplied with the handpiece.

Contraindications See the instructions for use supplied with the handpiece.

For Use With The PD Series Maestro Perforator Chuck is intended for use with the Consolidated Operating Room Equipment (CORE™) System Maestro Pneumatic Drills REF 5400-200-000 and 5400-201-000, and the Sumex® Drill REF 5400-130-000.

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Description The PD Series Maestro Perforator Chuck reduces handpiece speed by a ratio of 60:1.

User/Patient Safety WARNINGS: • Only trained and experienced healthcare professionals should use this equipment. • Before using any system component or any component compatible with this system, read and understand the instructions. Pay particular attention to WARNING information. Become familiar with system components prior to use. • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the care instructions manual supplied with the handpiece. • Upon initial receipt and before each use, operate the equipment and inspect each component for damage. DO NOT use any equipment if damage is apparent or the inspection criteria are not met. See the care instructions manual supplied with the handpiece for inspection criteria. • DO NOT apply excessive pressure, such as bending or prying, with a cutting accessory to prevent fracturing the accessory. • ALWAYS operate the equipment within the specified environmental condition values. See the Specifications section. • ALWAYS follow the recommended duty cycle to prevent the equipment from overheating. See the Specifications section. • When in use, attachments are applied parts. See the instructions for use supplied with the handpiece for information specific to applied parts.

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Accessories WARNINGS: • Use only Stryker-approved system components and accessories unless otherwise specified. • DO NOT modify any system component or accessory unless otherwise specified.

Bits • Upon initial receipt and before use, visually inspect the package for damage to confirm the integrity of the sterile barrier. Do not use the product if damage is apparent, the sterile barrier is compromised, or the package is unintentionally opened. • All cutting accessories are intended for single use only. Reuse significantly increases wear on the handpiece and attachment. • DO NOT reuse, reprocess, or repackage a single use device. A single use device is intended for a single use only. A single use device may not withstand chemical, chemical vapor, or high temperature sterilization reprocessing. Design features may make cleaning difficult. Reuse may create a serious risk of contamination and may compromise the structural integrity of the single use device resulting in operational failure. Critical product information may be lost if the single use device is repackaged. Failure to comply may lead to infection or crossinfection and result in patient and/or healthcare staff injury. • The Perforator Chuck accepts all Hudson-style perforator bits. Before use, read and understand the instructions supplied with the perforator bit. NOTES: • Sterile cutting accessories are sterilized by irradiation. • For a complete list of accessories, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

Definitions The symbols located on the equipment and/or labeling are defined in this section or in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment. SYMBOL

DEFINITION General warning sign

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Care Instructions For processing instructions and disposal/recycle information, see the care instructions manual supplied with the handpiece.

Instructions Assembly WARNINGS: • Operate the Perforator Chuck at the bit manufacturer's recommended speed. • DO NOT attach or remove any component while the handpiece is running. 1. Align the pins on the attachment with the small notches in the handpiece connector. Press the attachment onto the handpiece until it snaps into the connector.

2. Retract the chuck's retaining collar and install a perforator bit (flats aligned) until fully seated.

3. Release the retaining collar. Twist and pull the perforator bit to ensure it is secure. 4. Operate the handpiece and observe the perforator bit for any wobble. If wobble occurs, see the Troubleshooting section.

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5400-210-714 Rev-AB

Disassembly 1. Retract the chuck's retaining collar and withdraw the perforator bit. 2. Firmly pull the attachment away from the handpiece to disengage.

Troubleshooting WARNING: DO NOT disassemble or service this equipment, unless otherwise specified. NOTE: For service, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. PROBLEM

CAUSE

SOLUTION

Attachment difficult to attach or release from handpiece.

Connectors require a breaking-in period.

Install and remove the attachment repeatedly until connectors function smoothly.

Build-up of debris inside of attachment or drill connector.

See the care instructions manual supplied with the handpiece.

Attachment will not seat on handpiece.

Pins and notches are not lined up.

Realign pins and notches and push together firmly.

Bit wobbles.

Bit improperly installed.

Remove bit, rotate 180° and reinstall.

If wobble persists, bit may be worn or damaged.

Replace bit.

If wobble persists, indicates normal chuck wear.

Return chuck for service.

Build-up of debris in the attachment or handpiece connector.

Remove debris from inside of attachment and front of handpiece. See the care instructions manual supplied with the handpiece.

Attachment will not release from handpiece.

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Specifications WARNING: ALWAYS check any documentation that accompanies attachments and/or cutting accessories for special duty cycle and usage instructions. Model:

PD Series Maestro Perforator Chuck (REF 5400-210-060)

Dimensions:

5.0 inch [126.8 mm] length 1.3 inch [32.6 mm] diameter

Mass:

0.55 lb [250.2 g]

Equipment Type:

See the instructions for use supplied with the handpiece.

When used with CORE Sumex Drill (REF 5400-130-000): Mode of Operation:

Non-continuous Operation

Duty Cycle:

20 seconds on, 20 seconds off, 10 times

Rest Between Cycles:

40 minutes

When used with any other Stryker handpiece: See the instructions for use supplied with the handpiece. Maximum Temperature of Applied Part:

Less than 124 °F [51 °C] (Maximum surface temperature as tested to the standards listed under Product Safety Certification in the instructions for use supplied with the console.)

Applied Part:

When in use, attachments are applied parts. For more information, see the instructions for use supplied with the handpiece.

Environmental Conditions:

Operation

Storage and Transportation

Temperature Limitation: 85 %

Humidity Limitation: 10 %

Atmospheric Pressure Limitation:

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ES/DE/FR/IT/NL JA/ZH/KO SV/DA/FI/PT/NO PL/EL

5400-210-716 5400-210-721 5400-210-731 5400-210-751

Stryker Instruments 1941 Stryker Way Portage, Michigan (USA) 49002 1-269-323-7700 1-800-253-3210 2021-07

5400-210-714 Rev-AB

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